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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K844103
Device Name CARDIOPAC DEFIBRILLATOR 444
Applicant
Birtcher Corp.
4501 N. Arden Dr.
P.O. Box 4399
El Monte,  CA  91731
Correspondent
Birtcher Corp.
4501 N. Arden Dr.
P.O. Box 4399
El Monte,  CA  91731
Regulation Number870.5300
Classification Product Code
LDD  
Date Received10/23/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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